Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

Conditions

• HER2-expressing Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ZW25 (Zanidatamab) — DRUG
  ZW25 administered IV once weekly, once every 2 weeks, or once every 3 weeks. Part 1: in multiple increasing doses; Part 2: ZW25 given at the MTD, OBD, or an RD identified in Part 1; Part 3: ZW25 given at the MTD, OBD, or an RD combined with one of the following selected drug combination:
• Paclitaxel — DRUG
  Combination therapy with ZW25 - Part 3 Treatment Groups 1 and 4
• Capecitabine — DRUG
  Combination therapy with ZW25 - Part 3 Treatment Groups 2 and 5
• Vinorelbine — DRUG
  Combination therapy with ZW25 - Part 3 Treatment Groups 3 and 6
• Tucatinib — DRUG
  Combination therapy with ZW25 and Capecitabine - Part 3 Treatment Group 7
• Tucatinib — DRUG
  Combination therapy with ZW25 - Part 3 Treatment Group 8 (may be opened if recommended by the Safety Monitoring Committee and/or the sponsor)

Study Details

This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK).

Key Dates

Start date

Sep 30, 2016

Status verified

Nov 2024

Primary completion

Oct 31, 2024

Completion

Oct 31, 2024

Study Design

Enrollment

279 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ZW25 (Zanidatamab) Monotherapy and ZW25 Combination Therapy

Primary Outcome Measure

The proportion of patients who experience dose-limiting toxicities (DLTs) (Part 1) [ Time Frame: Up to 8 months ]

Locations (9)

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